inforMED
MalfunctionGCJ

SIGNATURE

Received Aug 21, 2023 · Event occurred Jun 7, 2023

Report 17583714 · MDR key 17583714

Device

Generic name

Laparoscope, General Plastic Surgery

Manufacturer

Silex Medical, Llc

Model number

5864000

Patient

23360 DA · Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

PRESTIGE LAP GRASPER BEING USED IN SURGERY, WHILE BEING USED INSIDE PATIENT, ONE OF THE JAWS OF THE GRASPER BROKE OFF. BROKEN PIECE WAS OBTAINED AND REMOVED FROM PATIENT. DEVICE SEQUESTERED.